Compressible mixing and delivery system for medical substances

ABSTRACT

A method of mixing and delivering a substance to a bone includes providing a compressible tube having a reservoir and using a mixing apparatus to mix a particulate solid and a mixing liquid to form the substance within the reservoir of the compressible tube. The method further includes using a compressing device to move the substance through an exit port in the compressible tube for delivery to the bone. The compressing device may be positioned on the compressible tube and the method may further include moving the compressing device along the compressible tube to empty the substance from the compressible tube. The substance may be a bone void filler, and the substance may be delivered from the exit port in the tube through a delivery apparatus, such as a cannula, to a target portion of the anatomy.

BACKGROUND

The present invention relates generally to the field of devices andmethods for delivering substances to bone. More particularly, thepresent invention concerns devices and methods for mixing and deliveringsubstances to the interior of fractured or otherwise injured bones,especially to the fracture interface.

Present methods of preparing a viscous surgical substance, such as abone void filler, to be introduced to fractured or injured bones involvecumbersome, multi-step processes. The process to form such a surgicalsubstance requires mixing a bulking agent with a reacting agent to formthe substance at the time of use, such as at the time of delivery to thetargeted area of the bone. Such methods may require mixing the elementsin a separate mixing container and manually transferring the material toa delivery container, such as a syringe. Not only is this methodlaborious, but can also create a mess at the mixing site. The amount oftime used to mix the elements and make this transfer can also add to theincreased viscosity of the substance, and make compression of thesyringe or delivery device for delivering the substance to a cannula orother delivery apparatus more difficult. Syringes can fail, which mayresult in waste of the substance therein, or require a further transferand additional clean-up. Furthermore, the compressive forces necessaryto make the transfer from the syringe can be difficult for many usersand preparers of the material.

SUMMARY

Various embodiments of the invention described herein allow for mixingand delivery of a substance (e.g., medication or bone void filler) to bedelivered to a target area of the body, such as a fracture site afterstabilization of the bone.

One embodiment of the invention relates to method of mixing anddelivering a substance to a bone including providing a compressible tubehaving a reservoir and using a mixing apparatus to mix a particulatesolid and a mixing liquid to form the substance within the reservoir ofthe compressible tube. The method further includes using a compressingdevice to move the substance through an exit port in the compressibletube for delivery to the bone.

The method may also include providing the particulate solid in thereservoir of the compressible tube, or alternatively, introducing theparticulate solid into the reservoir of the compressible tube. Themethod may also include introducing the mixing liquid into the reservoirof the compressible tube. The mixing liquid may be introduced to thereservoir through a sealable inlet portion. The compressible tube mayinclude a portal serving as the inlet portion and the exit port.

The method may also include moving the substance through the exit portand into a delivery apparatus for delivery directly to the bone. Thedelivery apparatus may be a cannula positioned within the body andhaving a distal portion position near the target portion of the anatomy.

The substance may be a bone void filler. The compressing device may bepositioned on the compressible tube and the method may further includemoving the compressing device along the compressible tube to empty thesubstance from the compressible tube. The compressing device may includea rolling key to roll the compressible tube to empty the substance fromthe compressible tube.

Another embodiment of the invention relates to a mixing and deliverysystem including a compressible tube having a reservoir configured formixing and holding a surgical substance. The compressible tube includesan inlet portion for accommodating the introduction of an element of thesurgical substance into the compressible tube. The compressible tubealso includes an exit port for enabling the delivery of the surgicalsubstance to a target portion of an anatomy. The system further includesa mixing apparatus configured to be received through the inlet portionof the compressible tube for mixing the elements of the surgicalsubstance to form the surgical substance.

The mixing and delivery system may also include a compressing deviceconfigured to move along the compressible tube and force the surgicalsubstance through the exit port. The exit port may be configured toengage with a delivery apparatus which delivers the surgical substanceto the anatomy. The delivery apparatus may be a cannula positionedwithin the body and having a distal portion position near the targetportion of the anatomy. The inlet portion may be sealable. Thecompressible tube may further include a portal serving as the inletportion and the exit port.

The reservoir of the compressible tube may contain a particulatesubstance and the fluid introduced through the inlet portion may be amixing liquid. The surgical substance may be a bone void filler.

Yet another embodiment of the invention relates to a kit for mixing anddelivering a surgical substance to an anatomy including a compressibletube having a reservoir configured for mixing and holding the surgicalsubstance, the compressible tube containing a particulate solid. Thecompressible tube includes a portion capable of being opened to receivea mixing liquid introduced into the reservoir. The compressible tubealso includes an exit port for enabling the delivery of the surgicalmaterial to a target portion of an anatomy. The kit further includes amixing apparatus configured to be inserted into the compressible tubefor mixing the particulate solid and the mixing liquid. The kit mayinclude a plurality of compressible tubes. The kit may also include atleast one compressing device configured to ride along the compressibletube and force the surgical substance through the exit port.

Alternative exemplary embodiments relate to other features andcombinations of features as may be generally recited in the claims.

BRIEF DESCRIPTION OF THE FIGURES

The disclosure will become more fully understood from the followingdetailed description, taken in conjunction with the accompanyingfigures, wherein like reference numerals refer to like elements, inwhich:

FIG. 1 illustrates a bone with a stabilizing wire and a hole in the bonearound the stabilizing wire.

FIG. 2 illustrates the bone and stabilizing wire shown in FIG. 1 with acannula introduced over the stabilizing wire, for delivery of a surgicalsubstance to a fracture in the bone.

FIG. 3 illustrates a longitudinal section view of a cannula with a capused in connection with a delivery system according to an exemplaryembodiment.

FIG. 4 illustrates a compressible delivery tube according to anexemplary embodiment.

FIG. 5 illustrates a mixing apparatus according to an exemplaryembodiment.

FIG. 6 illustrates a pinching apparatus to be used with the deliverysystem according to an exemplary embodiment.

FIG. 7 illustrates a pinching apparatus used on the compressible tube inaccordance with an exemplary embodiment of the delivery system.

DETAILED DESCRIPTION

Before turning to the figures, which illustrate the exemplaryembodiments in detail, it should be understood that the application isnot limited to the details or methodology set forth in the descriptionor illustrated in the figures. It should also be understood that theterminology is for the purpose of description only and should not beregarded as limiting. For example, a femur is illustrated in thedrawings, but the devices and methods described herein may be used inconnection with any bone in the body, including but not limited to bonesin the spine, arms, hands, legs, and feet. Furthermore, it should beunderstood that the exemplary embodiments described herein can also beused for the storage and mixing of other materials and substances. Forexample, though the description is directed to storing, mixing, anddelivery of bone void fillers and similar substances, the deliverysystem disclosed herein may also be used for the storage of stem cellsor bone marrow aspirate, and may accommodate mixing with othersubstances upon harvesting or at the time of delivery.

Referring to FIG. 1, a bone 10 includes a fracture 2. The fracture 2separates the bone into portions 10A and 10B. In surgical procedures torepair fractured bones, a stabilizing wire 4 may be used to hold boneportions together. The stabilizing wire 4 may be any type of wire usedto temporarily or permanently secure portions of bone together, such asKirschner wires or Steinmann pins. The stabilizing wire 4 is oftenplaced in a fractured bone 10 prior to insertion of a more permanentbone implant, such as a bone screw, nail, or other fixation structure.In addition to stabilizing the bone portions 10A and 10B, thestabilizing wire 4 may serve as a guide for a cannula, drill or boneimplant.

Various delivery apparatuses can be introduced over the stabilizing wire4 to deliver a surgical substance, such as a bone void filler to thefractured area of the bone, or other target area of the anatomy. Suchdelivery apparatuses may be elongated cannulas that carry the surgicalsubstance from the fluid/substance source, to the target area of theanatomy, and may be such cannulas as described in U.S. patentapplication Ser. No. 13/270,072, titled “Method and Device forDelivering Medicine to Bone,” filed Oct. 10, 2011, and herebyincorporated by reference herein in its entirety.

Referring to FIG. 2, according to an exemplary embodiment, amultichannel cannula 200 having, in a preferred embodiment, two or morechannels may be introduced over the stabilizing wire 4 to deliversubstances to the interior of bone 10. In one embodiment, themultichannel cannula is introduced over the stabilizing wire 4 aftercreation of hole 6, but prior to placement of a bone implant into thehole 6. A first channel of the multichannel cannula receives thestabilizing wire 4. The other channels of the multichannel cannula maybe used for delivering the surgical substance to the interior of bone10. The substance delivered using the multichannel cannulas describedherein may be any type of substance a user desires to deliver to theinterior of a bone, including growth factors or medication such as bonevoid fillers, calcium phosphate paste, an antibiotic, pain medication,or a chemotherapeutic agent.

The cannulas described herein can be made of any material suitable forplacement into a bone without harmful effects on the patient. In oneembodiment, the cannula is made of stainless steel or other type ofmetal. In another embodiment, the cannula is made of a rigid plastic,such as polyethylketone, that cannot be easily bent or manipulated intoalternative configurations. A rigid cannula may be advantageous toprovide stability when introducing the cannula into a hole 6 in a bone10. Furthermore, a rigid cannula provides stability for variousprocedures that a more flexible cannula may not provide. For example, ifa surgeon desires to use a plunger or other device to push a substancefrom the cannula and into the bone, a rigid cannula may be moredesirable. As another example, a rigid cannula is able to withstand moresignificant forces than a flexible cannula (e.g., forces applied to thecannula by a delivery device or a suction device, and the forcesresulting from movement of substances through the channels and throughany open portals in the cannula).

The cannulae that may be used to deliver the substance to the bone aresubstantially elongated structures with, in preferred embodiments, twoor more channels. The multichannel cannula 200 depicted in FIG. 2 anddescribed herein includes a first channel 201 having an open proximalend 224 and an open distal end 222. The open proximal end and opendistal end allow the first channel to be threaded over a stabilizingwire 4. Thus, the first channel 201 is configured to receive astabilizing wire 4. In one embodiment, the first channel 201 issubstantially cylindrical and has a diameter slightly larger than thediameter of the stabilizing wire. The side wall of the cylindrical firstchannel (as distinguished from the open ends of the first channel) maybe continuous, meaning there are no open portals or other openings alongthe side wall of the first channel. In one embodiment, liquid cannotpenetrate the side wall of the first channel.

The multichannel cannula shown in FIG. 2 further includes a secondchannel 202. The second channel 202 includes at least one inlet portal220 and at least one exit portal (e.g., open distal end 210). In somemethods described herein, the inlet portal 220 of the second channel 202serves as an inlet for the surgical substance to be delivered to theinterior of a bone. In these embodiments, the exit portal 210 of thesecond channel serves as an outlet for the substance. The inlet portaland exit portal of the second channel are thus in fluid communication toallow substances or materials to be delivered to the interior of a bone.

As shown in FIG. 3, multichannel cannula 200 may also include a cap 320.The cap 320 has a housing portion with a channel for coupling to aportion of the proximal end of cannula 200. The channel of the cap 320may extend from first end through a second end of the housing portionfor receiving the stabilizing wire 4 therethrough. In a preferredembodiment, the cap 320 is affixed to the multichannel cannula 200, suchas during production of the cannula 200. In an alternative embodiment,the cap 320 may be removable. The cap 320 may be positioned at the siteof the hole in the bone, such as hole 6, in order to serve as a plug. Inthis way, cap 320 can plug the hole 6 and may prevent irrigation orother substance being delivered to the site from coming back up throughthe hole 6 in the bone. In another embodiment, a separate temporary plugor seal may be added to the cannula to plug the hole 6 in the bone. Inthe embodiment shown, cap 320 also has a delivery portal 322. Thedelivery portal 322 is coupled to an inlet portal of the second channel202 such that a substance can flow from the delivery portal 322, throughthe inlet portal, and into the second channel 202.

Various delivery systems can be coupled to the delivery portal 322 toassist in delivering substances to the second channel 202 ofmultichannel cannula 200, and ultimately to the bone. Tubing may be usedto connect the delivery system to the delivery portal 322. The type ofdelivery system selected by a user may depend on the type of substanceto be delivered to the bone.

One such delivery system is a mixing and delivery system 400, asdepicted in FIGS. 3-7. While shown in use with the cannula 200, thedelivery system 400 according to various exemplary embodiments can alsobe used with other delivery apparatuses, other than the cannulas shownand described above, such as a different cannula, a catheter, or adelivery needle.

As shown in FIG. 4, the mixing and delivery system 400 includes aflexible, compressible tube 401. The compressible tube 401 includes areservoir 402 that is configured to hold and/or receive elements to bemixed together for forming a surgical substance. In one embodiment, theelements for forming a bone void filler are a particulate substance anda mixing liquid, such as a bulking agent and a reacting agent. Inanother embodiment, one of the elements may be a component containingstem cells or bone marrow aspirate that may be mixed with a secondelement at the time of harvest, or prior to delivery. In yet anotherembodiment, the first element may be a prepared paste or fluid, to bemixed with a second fluid element. The reservoir 402 is of sufficientsize and shape such that the mixing of the elements to form the surgicalsubstance can take place therein. The reservoir 402 is in fluidcommunication with at least one portal 404 of the compressible tube 401.The portal 404 may serve as both an inlet and an exit portal, or thedelivery tube may have more than one portal, one serving as an inletportion separate from and in addition to an exit portal. The portal 404,or an alternative inlet portion such as a sealable opening, allows forintroduction of, for example, the mixing liquid to the particulate solidheld in the reservoir 402. The portal 404 is preferably sealable so asto contain the first element, such as a particulate solid, and/or thesurgical substance within the reservoir when introduction of the secondelement, such as the mixing liquid, or delivery of the surgicalsubstance is not taking place. The compressible tube 401 also has anexit portal, which may also be portal 404, through which the mixed andprepared surgical substance is delivered to a delivery apparatus, suchas the cannula 200 discussed herein, directly to a target area, or toanother device to hold the surgical substance.

In an exemplary embodiment, the portal 404 is both the inlet and theexit portal. In an alternative exemplary embodiment, the portal 404serves as an exit portal only, and the opposing end 405 is open, or ableto be opened and resealed, such that introduction of the mixing liquidand performance of the mixing (described below) can be accomplishedthrough the opposing end 405.

In certain embodiments, the compressible tube 401 has a false bottom,wherein the tube has an internal partition constituting a wall of thereservoir 402 portion of the compressible tube 401. In otherembodiments, the reservoir 402 comprises the entirety of the area withinthe compressible tube 401 structure. The compressible tube 401, inpreferred embodiments, is made of a transparent material to enablevisualization of the mixing of the surgical substance. In this way, apractitioner is able to witness and guide the progress of the mixing anddetermine when the surgical substance is appropriately formed.

Referring to FIG. 5, in an exemplary embodiment, mixing and deliverysystem 400 also includes a mixing apparatus 410. The mixing apparatus410 may be a blender or other device suitable for mixing the particulatesolid with the mixing liquid. The mixing apparatus 410 may be anyblender, agitator, or mixer suitable for mixing medical substances. Asshown in the embodiment of FIG. 5, the mixing apparatus 410 includes ahandle/housing portion 412 for managing and manipulating the mixingapparatus 410 and a mixing portion 414. The mixing portion 414, asshown, is an elongated portion that is configured to be received throughthe inlet portion of the compressible tube 401, such that the mixing andforming of the surgical substance can take place within the reservoir402.

Mixing and delivery system 400 may also include a compressing device,such as the compressing device 420 shown in FIG. 6. The compressingdevice 420 may have a slotted portion 422 configured to receive aportion of the compressible tube 401 therethrough. The compressingdevice 420 may be separate from the compressible tube 401, or may beintegrated into the compressible tube 401. The compressing device 420 isconfigured to move along the length of the compressible tube 401,compressing the compressible tube 401 so as to force the surgicalsubstance through the exit portal of the compressible tube 401, as shownin FIG. 7, and to the cannula, catheter, needle, or other chosendelivery apparatus. In particular, the compressing device 420 may have arolling key 424 that moves along or rolls the compressible tube 401 byway of manual manipulation of a key flange 426, and that causes thecompression of the compressible tube 401 and forces the surgicalsubstance from the reservoir 402.

One method of mixing and delivering a surgical substance to bone, suchas a bone void filler, according to an exemplary embodiment includesproviding a compressible delivery tube, such as compressible tube 401,wherein the compressible tube 401 has a reservoir 402. The compressibletube 401 may be provided with a first element therein, such asparticulate solid or a prepared paste or fluid, or the first element maybe introduced into the reservoir 402 through the portal 404. A mixingapparatus 410, such as a blender, mixing, or agitator, is introduced tothe reservoir 402 of the compressible tube 401 after or duringintroduction of a second element, such as the mixing liquid to thereservoir 402. As described above, the second element, such as themixing liquid, may be introduced through the portal 404 or through analternative inlet portion of the compressible tube 401. The mixingapparatus 410, likewise, may be introduced through the portal 404 orthrough an alternative inlet portion of the compressible tube 401. Themethod further includes moving the surgical substance through the exitport of the compressible tube 401 for delivery to the body. Delivery tothe body may take place through a cannula as described above, or mayalternatively take place through a catheter, delivery needle, or otherdelivery apparatus. Moving the surgical substance through the exit portof the compressible tube 401 may use a compressing device 420 whichmoves along the length of the compressible tube 401 to force thesurgical substance through the portal 404 of the compressible tube 401.

The construction and arrangement of the devices and methods as shown inthe various exemplary embodiments are illustrative only. Although only afew embodiments have been described in detail in this disclosure, manymodifications are possible (e.g., variations in sizes, dimensions,structures, shapes and proportions of the various elements, use ofmaterials, orientations, etc.). For example, the position of elementsmay be reversed or otherwise varied and the nature or number of discreteelements or positions may be altered or varied. Accordingly, all suchmodifications are intended to be included within the scope of thepresent disclosure. The order or sequence of any process or method stepsmay be varied or re-sequenced according to alternative embodiments.Other substitutions, modifications, changes, and omissions may be madein the design, operating conditions and arrangement of the exemplaryembodiments without departing from the scope of the present disclosure.

What is claimed is:
 1. A method of mixing and delivering a substance toa bone, comprising: providing a compressible tube having a reservoir;mixing a first substance element and a second substance element using amixing apparatus to form the substance within the reservoir of thecompressible tube; delivering the substance through an exit port in thecompressible tube for delivery to the bone using a compressing device.2. The method of claim 1, wherein the first substance element is aparticulate solid and the second substance element is a mixing liquid.3. The method of claim 1, further comprising providing the first elementin the reservoir of the compressible tube.
 4. The method of claim 1,further comprising introducing the first element into the reservoir ofthe compressible tube.
 5. The method of claim 1, further comprisingintroducing the second element into the reservoir of the compressibletube.
 6. The method of claim 1, further comprising moving the substancethrough the exit port and into a delivery apparatus for deliverydirectly to the bone.
 7. The method of claim 6, wherein the deliveryapparatus is a cannula positioned within the body and having a distalportion position near a target portion of the bone.
 8. The method ofclaim 1, wherein the substance is a bone void filler.
 9. The method ofclaim 1, wherein the compressing device is positioned on thecompressible tube and wherein the method further comprises moving thecompressing device along the compressible tube to empty the substancefrom the compressible tube.
 10. The method of claim 9, wherein thecompressing device comprises a rolling key to roll the compressible tubeto empty the substance from the compressible tube.
 11. The method ofclaim 1, wherein the second element is introduced to the reservoirthrough a sealable inlet portion.
 12. The method of claim 11, whereinthe compressible tube further comprises a portal comprising the sealableinlet portion and the exit port.
 13. The method of claim 1, wherein thefirst element comprises one of stem cells and a bone marrow aspirate.14. The method of claim 1, wherein the first element is a paste materialand the second material is a mixing liquid.
 15. A mixing and deliverysystem, comprising: a compressible tube comprising: a reservoirconfigured for mixing and holding a surgical substance; an inlet portionfor accommodating introduction of an element of the surgical substanceinto the compressible tube; and an exit port for enabling the deliveryof the surgical substance to a target portion of an anatomy; and amixing apparatus configured to be received through the inlet portion ofthe compressible tube for mixing elements of the surgical substance toform the surgical substance.
 16. The mixing and delivery system of claim15, further comprising a compressing device configured to move along thecompressible tube and force the surgical substance through the exitport.
 17. The mixing and delivery system of claim 15, wherein the inletportion is sealable.
 18. The mixing and delivery system of claim 15,wherein the surgical substance is a bone void filler.
 19. The mixing anddelivery system of claim 15, wherein the exit port is configured toengage with a delivery apparatus which delivers the surgical substanceto the anatomy.
 20. The mixing and delivery system of claim 19, whereinthe delivery apparatus is a cannula positioned within the body andhaving a distal portion position near the target portion of the anatomy.21. The mixing and delivery system of claim 15, wherein the reservoir ofthe compressible tube contains a particulate substance and the elementintroduced through the inlet portion is a mixing liquid.
 22. The mixingand delivery system of claim 15, wherein the compressible tube furthercomprises a portal comprising the inlet portion and the exit port.
 23. Akit for mixing and delivering a surgical substance to an anatomy,comprising: a compressible tube comprising: a reservoir configured formixing and holding the surgical substance, the reservoir containing aparticulate solid; an inlet portion capable of being opened to receive amixing liquid introduced into the reservoir; an exit port for enablingthe delivering of the surgical substance to a target portion of theanatomy; and a mixing apparatus configured to be inserted into thecompressible tube for mixing the particulate solid and the mixingliquid.
 24. The kit of claim 23, further comprising a plurality ofcompressible tubes.
 25. The kit of claim 23, further comprising at leastone compressing device configured to ride along the compressible tubeand force the surgical substance through the exit port.